Repeat Sternotomy for Pediatrics

Congenital Disorders Clinical Trial

Official title:

Repeat Sternotomy for Pediatric Cardiac Surgery: Indications, Risks and Results

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00485745
• Other study ID #: 07-023
• Status: Completed
• Phase: N/A
• First received: June 12, 2007
• Last updated: November 25, 2014
• Start date: January 2002
• Est. completion date: November 2009

Study information

• Verified date: November 2014
• Source: Children's Healthcare of Atlanta
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

Given the relative lack of information regarding the risks associated with repeat sternotomy in the pediatric patient population, a preliminary screen of the Children's Cardiothoracic Surgery Database was performed to determine how many repeat sternotomies have been performed at this institution within the last 4 years. A total of 1281 repeat sternotomies were identified during this time period.

We propose a retrospective review of the indications, potential risk factors, and short-term outcomes for these procedures. These data would allow a multivariable regression analysis to identify risk factors associated with adverse events during repeat sternotomy.

Description:

Median sternotomy is the most common approach for cardiac surgery in adults and children. While the initial sternotomy is rarely associated with adverse events, the risks associated with repeated sternotomies for subsequent reoperations may be higher. This increased risk is primarily due to adhesions securing cardiac structures to the sternum, thus placing those structures at risk for injury during sternal re-entry. There have been several large studies examining the frequency and impact of adverse events during repeat sternotomy in adults. Roselli and colleagues from the Cleveland Clinic reviewed 1853 consecutive repeat sternotomies and found a 6.8% incidence of serious adverse events. 1 This study can be contrasted against the report of O'Brien and colleagues which reviewed the results of 546 repeat sternotomies performed over 21 years in Brisbane, Australia with only 9 (1.6%) minor cardiac injuries and no major adverse events. 2

The pediatric cardiac surgical field is somewhat different from the adult realm in that re-operations are more common, either due to planned, staged palliation requiring multiple operations or the expected failure of implanted conduits and valves which subsequently require replacement. However, while the incidence of repeat sternotomy is higher in the pediatric population, the overall number of patients is considerably smaller, so there has been a relative dearth of information in the literature regarding the risks and outcomes associated with repeat sternotomy. The largest series reported was published by Russell and colleagues in 1998 and included only 192 repeat sternotomies performed on 165 patients. 3 The authors reported a 5.2% incidence of cardiac laceration with selective utilization of femoro-femoral bypass to decompress the heart during repeat sternotomy for "higher risk" patients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1281
• Est. completion date: November 2009
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 21 Years

Eligibility

Inclusion Criteria:

• Repeat sternotomy at Children's Healthcare of Atlanta between 1.1.02 and 12.31.06

• patient under 21 years of age

• "repeat" is defined as a sternotomy performed more than 1 month after the most recent previous sternotomy

Exclusion Criteria:

• Those charts that do not meet inclusion criteria

Study Design

Time Perspective: Retrospective

Related Conditions & MeSH terms

• Congenital Disorders

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Children's Healthcare of Atlanta

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Retrospective medical record review evaluating preoperative and intraoperative variables associated with repeat sternotomy as risk factors for adverse events.	This study will be a retrospective medical record review evaluating preoperative and intraoperative variables associated with repeat sternotomy as risk factors for adverse events. Short-term outcomes including ventilator time, intensive care unit and hospital length of stay, blood product utilization, and transfusions will be analyzed to determine the effect of adverse events.	Length of stay	No